The Staff Systems Engineer will be responsible for providing leadership to cross functional teams to develop industry-leading DNA sequencing instruments for clinical applications in an exciting, fast-paced environment. The foundation of all activities for this role is a wide, solid grasp of multiple areas of engineering physics and molecular biology, and the ability to climb new learning curves quickly. Primary responsibilities include mapping complex workflows, development of system models/budgets, contributing to system & sub-system architecture, and developing test strategies for critical parameter understanding and verification. The candidate should possess strong organizational and communication skills to facilitate successful product development across hardware, consumable, firmware, software, and chemistry teams.
The ideal candidate has experience bringing regulated medical instruments to market.
Build the information foundation for successful architecture activity. Create and maintain documents, models, & diagrams describing functional workflows. Examples include biochemistry workflows, hardware timing diagrams, and assembly process workflows.
Develop system models that guide design decisions. These can include system tolerance budgets, performance models, COGS models, etc. Provide mentorship to sub-system engineers in the development of models that guide lower level design decisions.
Support architecture definition by working across sub-system design teams to align overlapping design requirements /constraints and drive teams in developing concepts, evaluating risks, and efficiently concluding on a design path.
Develop, manage, execute test strategies for Critical Parameter Management which identify the sensitivities and acceptable operating ranges for input parameters relative to output metrics. Leverage Design of Experiments for efficient coverage of complex parameter space.
Own the seams between teams, especially including the definition and documentation of inputs/outputs between hardware sub-system design and other teams such as software, firmware and electrical engineering teams.
Lead teams through complex root-cause analysis in which there are many possible root causes that involve various areas of physics. Mentor others on systematic best practices for problem solving (8D method, fish-bone diagrams, etc.).
Manage teams and projects including planning, scheduling, budgeting, and reporting. Teams will include both internal engineering teams and external design & manufacturing partners.
Required Skills & Experience:
Engineering or Physics M.S. with at least 8 years of experience or Ph.D. with 2 - 5 years of experience in instrumentation design.
Demonstrated track record of rapidly climbing steep learning curves. Enthusiasm for tackling tough problems on an aggressive schedule.
Experience developing products in a regulated environment (FDA 510k approval process).
Strong analytical background, with record of using system models to drive decisions.
Strong communication and presentation skills (ability to distill complex technical information into product decisions and business recommendations).
Demonstrated experience with characterization and testing of complex systems, including design of experiments and root cause analysis.
Proven performance in product development in an industrial setting, bringing a product from concept to commercial launch.
Preferred Skills & Experience:
Technically proficient in disciplines including optics, microfluidics, heat transfer, precision motion, and electronics.
Experience with a wide range of manufacturing technologies including high precision techniques, low cost/high volume techniques, micro-fabrication techniques, design for manufacturing, and design for reliability.
Fluency in the methods and vocabulary of nucleic acid analytical techniques and molecular biology.
Specific experience with product development for laboratory instrumentation for biological analysis.
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